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Trial record 17 of 85 for:    Recruiting, Not yet recruiting, Available Studies | "Anterior Cruciate Ligament"

The Safety and Effectiveness of PEEK Interference Screws in Anterior Cruciate Ligament Reconstruction

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ClinicalTrials.gov Identifier: NCT03342222
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : April 30, 2018
Sponsor:
Collaborator:
Rejoin Hangzhou Martins Medical Equipment Co., Ltd.
Information provided by (Responsible Party):
Hongbin Lu, Central South University

Brief Summary:

Anterior cruciate ligament (ACL) rupture is one of the most common injuries in sports medicine. ACL reconstructions are usually performed to restore the stability of knee joint and prevent the secondary meniscal and chondral lesions.

120 Subjects with ACL injury were randomly assigned to two groups for ACL reconstruction.Group one: tibial fixation with PEEK Interference Screws (Rejoin Hangzhou Martins Medical Equipment Co., Ltd.);Group two: tibial fixation with Biosure PK interference screw (Smith & Nephew plc). The subjects will be followed by 12 months after surgery for evaluations.Outcome measures included Lysholm score,IKDC, ADT,Lachman.


Condition or disease Intervention/treatment Phase
PEEK Interference Screw; Fixation; Anterior Cruciate Ligament Reconstruction Device: Interference Screws Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center, Randomized, Open, Parallel, Noninferiority Clinical Trial to Evaluate the Safety and Effectiveness of PEEK Interference Screws in Anterior Cruciate Ligament Reconstruction
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : November 20, 2019
Estimated Study Completion Date : November 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PEEK Interference Screws
PEEK Interference Screws provided by Ruijin Hangzhou Martins Medical Equipment Co., Ltd.
Device: Interference Screws
tibial fixation for ACL reconstruction

Active Comparator: Biosure PK interference screw
Biosure PK interference screw from Smith & Nephew plc.
Device: Interference Screws
tibial fixation for ACL reconstruction




Primary Outcome Measures :
  1. percentage of patients with Lysholm score more than 70 score [ Time Frame: 12 month ]

Secondary Outcome Measures :
  1. Lysholm score [ Time Frame: 1month; 3month; 6 month; 12 month ]
  2. IKDC [ Time Frame: 1month; 3month; 6 month; 12 month ]
  3. Anterior drawer test [ Time Frame: 1month; 3month; 6 month; 12 month ]
  4. Lachman test [ Time Frame: 1month; 3month; 6 month; 12 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Voluntarily sign the informed consent form; Between the ages of 18 and 75; Positive ADT and positive Lachman test. Unilateral anterior cruciate ligament is confirmed by MRI (without posterior cruciate ligament injury or reconstruction); Tolerated for anterior cruciate ligament reconstruction surgery; Normal contralateral knee

Exclusion Criteria:

  1. Do not meet the diagnostic criteria of anterior cruciate ligament injury;
  2. With posterior cruciate ligament fracture at the same time;
  3. X-ray showed a significant degeneration of the knee (more than four degrees of cartilage injury);
  4. Knee flexion less than 90 degree;
  5. Abnormal body anatomy;
  6. Pregnant, breast-feeding or subjects who plan to become pregnant;
  7. Serious osteoporosis, malignant tumors;
  8. Allergic to implant materials;
  9. Patients with severe malnutrition who can not tolerate surgery;
  10. Severe coagulopathy, such as hemophilia;
  11. Immunodeficiency diseases, including those requiring long-term use of immunosuppressive agents;
  12. The injured knee has a wide range of skin diseases;
  13. Serious obese patients (BMI> 35);
  14. Patients with severe mental illness can not cooperate with postoperative rehabilitation and patients with severe cardiopulmonary disease can not tolerate surgery;
  15. Ipsilateral lower extremity received surgery within the past year;
  16. Has participated in any other clinical trial in the past three months;
  17. Can not comply with the requirements of the study;
  18. Those who the investigator thinks they are inappropriate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342222


Contacts
Contact: Xi He, MD 86-073189753059 hongbinlu@hotmail.com

Locations
China, Hunan
Xiangya Hospital, Central South University Recruiting
Changsha, Hunan, China, 410008
Contact: Lu Hongbin, M.D. & Ph.D.    86-0731-84327174    hongbinlu@hotmail.com   
Sponsors and Collaborators
Central South University
Rejoin Hangzhou Martins Medical Equipment Co., Ltd.

Responsible Party: Hongbin Lu, Porfessor, Central South University
ClinicalTrials.gov Identifier: NCT03342222     History of Changes
Other Study ID Numbers: JMST-01
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hongbin Lu, Central South University:
PEEK Interference Screw; Fixation; Anterior Cruciate Ligament Reconstruction